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Judith Hutcheson, Lyle Bowman, Kamran Hosseini; Safety of DuraSite vehicle as part of a topical treatment in cataract surgery patients. Invest. Ophthalmol. Vis. Sci. 2013;54(15):1093.
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To investigate the safety of DuraSite vehicle (polycarbophil, sodium chloride, edetate disodium dihydrate, and sterile water for irrigation) in post cataract surgery patients.
In a well-controlled multicenter Phase II clinical trial, 169 patients were randomized into 4 different groups to investigate different dosing regimens of Bromfenac in DuraSite 0.075% (ISV-303) compared with the non DuraSite based commercial Bromfenac formulation (0.09%). DuraSite was the vehicle (either with or without the drug) in three arms of the study (approximately 3/4 of the total patients, n=127). All patients received the investigational medication one day after cataract surgery, and self-administered the formulation b.i.d. for a period of two weeks. Slit-lamp biomicroscopy, IOP measurement and visual acuity test were performed on 4 clinical visits while ophthalmoscopy was performed on Days 1 and 29. All patients received a safety examination at Days 8, 15 and 30 post dosing.
The incidence of adverse events for all DuraSite containing arms, ISV-303 BID, ISV-303 QD and DuraSite Vehicle BID was comparable to the active control of commercial Bromfenac 0.09% BID. No major differences were observed in BCVA, IOP, or ophthalmoscopy evaluations.
DuraSite-containing ophthalmic formulations are well tolerated for use in cataract surgery patients as shown in a well-controlled multicenter clinical trial.
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